GSK (GSK.L) agreed to an exclusive strategic collaboration with Hong Kong-listed Sino Biopharmaceutical that will see the British pharmaceutical giant's potential treatment for chronic hepatitis B get scaled access to over 5,000 medical centers in mainland China at launch.
Bepirovirsen was accepted for priority regulatory review in China in April on the back of positive results from the B-Well 1 and B-Well 2 phase 3 trials, according to a Monday release. The trials showcased statistically significant and clinically meaningful functional cure rates for hepatitis B, which can cause both acute and chronic liver disease.
Under the initial 5.5-year deal, Sino Biopharmaceutical unit Chia Tai Tianqing Pharmaceutical Group will purchase the drug from GSK and handle its import, distribution, hospital access, and commercialization in mainland China. The term may be extended, subject to mutual agreement.
Meanwhile, GSK will retain marketing authorization and remain responsible for regulatory, quality, pharmacovigilance, and global strategy matters. The global biopharma company will also be able to review certain early-stage pipeline assets of Sino Biopharmaceutical to evaluate the potential for collaboration opportunities outside China.
Besides its priority review and breakthrough therapy designation in China, bepirovirsen has received priority review, fast track and breakthrough labels from the US Food and Drug Administration, and SENKU designation in Japan for an expedited assessment.
